MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-14 for MOUTH PROP C271114 manufactured by Dentsply Rinn.
[2802281]
In this event it was reported that a pediatric pt experienced an allergic reaction after use of a mouth prop during a dental procedure.
Patient Sequence No: 1, Text Type: D, B5
[10125866]
It was determined that the product does contain nickel. Allergic reaction to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418963-2012-00001 |
| MDR Report Key | 2705766 |
| Report Source | 05 |
| Date Received | 2012-08-14 |
| Date of Report | 2012-07-19 |
| Date of Event | 2012-07-12 |
| Date Mfgr Received | 2012-07-19 |
| Date Added to Maude | 2012-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY RINN |
| Manufacturer Street | 1212 ABBOTT DR. |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH PROP |
| Product Code | BRW |
| Date Received | 2012-08-14 |
| Catalog Number | C271114 |
| Lot Number | 1006367 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY RINN |
| Manufacturer Address | ELGIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-14 |